Manufacturing Technician-Medical Device-Contract-Santa Clara, Ca
- Materials and Inventory management for Pilot Line processes
- Work Order and Non-conformance management for Pilot Line processes via ERP
- Assemble various catheter designs and assist in developing design improvement, assembly approaches, and fixtures for articulating catheter devices.
- Execute rework or deviation instructions with coordination with manufacturing engineering.
- Identifies and escalates nonconforming products and supports root cause investigation alongside manufacturing engineering.
- Perform testing, experimentation, and analysis.
- Meet catheter Pilot Line yield and productivity goals.
- Support processes and equipment qualification activities
- Train manufacturing/Pilot Line operators and Technician processes and techniques
- Assist manufacturing/Pilot line/process/R&D engineers in resolving product and process problems.
- Complete documentation such as Lot History Records per GMP requirements
- Support the introduction of new products onto the manufacturing line.
- Follow GMP guidelines
- Support experimentation to uncover key relationships between process variables and product performance.
- Identifies and escalates nonconforming products and supports root cause investigation alongside manufacturing engineering
- Provide day-to-day coordination and scheduling of floor activities with materials and planning Pilot Line teams.
- Hands on Interview for New employees on Pilot Line.
- Assist in the selection of new employees as required to meet business needs.
- Provide timely feedback to employees on performance.
- Communicate with staff on a regular and consistent basis as defined.
- Keep management informed of issues & concerns in a timely manner.
- Ensure staff are trained in all relevant procedures.
- Ensure housekeeping standards are maintained within areas of charge.
Required Knowledge/Skills, Education, And Experience
- High school degree
- 5+ years of experience with medical field or relevant companies is required.
- Computer programs required; Ability to work with Excel, Word, Agile, SAP are preferred.
- Have knowledge for end-to-end processes and have hands on skill set equivalent to operator III level.
- Work on pilot line supporting new product development and able to build prototypes and provide feedback to engineers.
- Support activities related to equipment qualification or process validation.
- Able to execute protocols and document test results or draft work instructions.
- Red line or create procedures electronically.
- Able to perform simple failure analysis independently or assist engineers for more complicated failure analysis and able to provide feedback or ideas for continuous improvement.
- Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820.
Please send resume to firstname.lastname@example.org